Effectiveness of Recombinant Human Growth Hormone Therapy for Children With PMS

Primary outcomes

1. level of serum IGF-1 and IGFBP-3

   Time frame: 3 months

   All laboratory indices were completed in the morning while the participants fasted and were analysed by the laboratory of the investigators' hospital.

2. Chinese version of the Gesell Development Scale (GDS)

   Time frame: 3 months

   To measure neuropsychological development. The development quotient (DQ) in the GDS was used to quantify neurodevelopment, which can indicate the level of neurodevelopment and is interpreted as follows: DQ=86 as normal, DQ 76 to 85 as marginally delayed, DQ at 55-75 as slightly delayed, DQ at 40 to 54 as moderately delayed, and DQ⩽39 as severely delayed.

3. Simplified Chinese version of the Aberrant Behavior Checklist (SC-ABC)

   Time frame: 3 months

   Different from its English version that created by Krug in 1980 , SC-ABC was based on the study of Krug in 2009, in which proved ABC can be used in 14 months children, then it was translated into Simplified Chinese by the researchers of Peking University Sixth Hospital. To date, the SC-ABC scale has been verified and widely used for more than 10 years to assess the changes of symptoms in Chinese children aged from 14 months to 14 years old with behavioral problems.

   This checklist includes 57 items and five subscales: sensory behavior, social relating, body and object use, language and communication skills, and social and adaptive skills. Each item was scored from 0 to 3,with higher scores indicate more severe symptoms.

4. Adverse events

   Time frame: 3 months

   Adverse events (AEs) were measured during the trial during via monitoring visits or phone calls using an adapted semi-structured interview every two weeks